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Full Description
Translational Gastroenterology covers the principles of evidence-based medicine and applies these principles to the design of translational investigations. Readers will learn important concepts, including case-control study, prospective cohort study, randomized trials, and reliability study. Medical researchers will benefit from greater confidence in their ability to initiate and execute their own investigations, avoid common pitfalls in gastroenterology, and know what is needed in collaboration. Further, this title is an indispensable tool in grant writing and funding efforts. The practical, straightforward approach helps the aspiring investigator navigate challenging considerations in study design and implementation.
The book provides valuable discussions of the critical appraisal of published studies in gastroenterology, allowing the reader to learn how to evaluate the quality of such studies with respect to measuring outcomes and to make effective use of all types of evidence in patient care. In short, this practical guidebook will be of interest to every medical researcher or gastroenterologist who has ever had a good clinical idea but not the knowledge of how to test it.
Contents
PART I: CONCEPT
1. Introduction to clinical research
2. The question
3. Study population
4. Outcome measurements
PART II: STUDY TYPES
5. Design principles
6. Case series
7. Case-control study
8. Cohort study
9. Cross-section study
10. Clinical trials
11. Meta-analysis
12. Cost-effectiveness study
13. Diagnostic test evaluation
14. Reliability study
15. Database studies
16. Surveys and questionnaires
17. Qualitative methods and mixed methods Definition of the study type
PART III: CLINICAL TRIALS
17. Randomized control
18. Nonrandomized control
19. Historical control
20. Cross-over
21. Withdrawal studies
22. Factorial design
23. Group allocation
24. Hybrid design
25. Large, pragmatic
26. Equivalence and noninferiority
27. Adaptive
28. Randomization
30. Multicenter considerations Study design and practical considerations
PART IV: PLANNING
31. Optimizing the question
32. Meaningful outcome measurements
33. Sample size Power analysis
34. Budgeting Funding, timeline, personnel, materials
35. Ethics and review boards
36. Regulatory considerations for new drugs and devices
37. Funding approaches
38. Research team
39. Subject recruitment
40. Data management
41. Quality control
42. Report forms
43. Subject adherence
44. Survival analysis
45. Monitoring committee in clinical trials
PART V: STATISTICAL PRINCIPLES
46. Presenting data
47. Common issues in analysis
48. Basic statistical principles
49. Distributions Description, examples, implications in analysis.
50. Hypotheses and error types
51. Power Detecting effects
52. Regression Explanation
53. t-test Explanation
54. Chi-square Explanation
55. Analysis of variance Explanation
56. Correlation Explanation
57. Biases